Catheter with disruptable guidewire channel

ABSTRACT

The present invention is a catheter device that includes a disruptable guidewire channel. The guidewire channel is configured to provide necessary trackability of the catheter along the guidewire during introduction of the catheter to a treatment site. Once treatment is completed, the guidewire channel can then be disrupted so as to free the guidewire from the catheter in situ. The apparatus of the present invention provides distinct advantages over existing over-the-wire and rapid exchange catheter introduction methods, including the ability to achieve much faster treatment implement exchanges, the ability to rapidly deliver multiple treatment implements in series, and the ability to maintain multiple treatment implements simultaneously at a treatment site using a single guidewire.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of commonly owned and U.S.patent application Ser. No. 10/346,599, filed on Jan. 17, 2003, nowabandoned entitled Catheter with Disruptable Guidewire Channel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to catheter systems for delivery ofmedical devices into a patient, and particularly to medical devices thatare delivered to a treatment site using a guidewire.

2. Description of Related Art

Minimally invasive (or “interventional”) medical procedures are commonlyemployed today to avoid the substantial effort and trauma inherent intraditional surgery. Instead of directly accessing a treatment sitethrough surgical procedures, a physician will make a small incision intoa remote vessel (e.g., a femoral artery) and guide the necessary toolsto the treatment site using fluoroscopy or other visualizationtechniques. Access to the treatment site is first achieved using verylow profile devices that can be “steered” through the various branchesof vessels to the correct treatment location. Typically these initialsmall diameter devices will be a steerable guidewire or a small-diameterguiding catheter that is followed by insertion of a guidewire. Once inthe correct position, treatment devices can then be attached to theguidewire and advanced to the treatment site along the guidewire like atrain traveling along a track. Following treatment, each treatmentdevice is then pulled out of the patient along the same guidewire toallow, if needed, further treatment devices to be advanced along theguidewire to the treatment site.

This basic approach is now used in a wide variety of medical procedures,including internal vessel repairs (e.g., repairing aneurysms in theaorta or other vessels using grafts or stent-graft devices) and treatingblockages in vessels (e.g., performing balloon angioplasty orthrombectomy, and stent or stent-graft placements). All of theseprocedures tend to be much faster and far less traumatic than comparablesurgical treatments. As a result, there are a host of benefits by usingthese procedures, including: fewer medical professionals need to attendthe procedures; the procedures can be completed more rapidly; thepatient may need far less extensive anesthesia and, where appropriate,can be awake and cooperative during the procedure; and since the traumaof open surgery is avoided overall hospital stays are dramaticallyreduced (e.g., for the repair of an abdominal aortic aneurysm hospitalstays can be reduced from over a week including intensive care to only acouple of days or less).

Two basic categories of techniques are commonly used today to advancetreatment apparatus to a treatment site along a guidewire. First, “overthe wire” (OTW) techniques employ a long guidewire that extends far outof the patient's body. In the OTW procedures, each treatment device ismounted on a catheter that includes a guidewire lumen extending theentire length of the catheter. The physician threads each cathetercompletely over the length of the guidewire extending out of the patientand, while an assistant controls the tail end of the guidewire, thephysician feeds the catheter to the treatment site. Following treatment,the entire catheter is then removed along the guidewire, again with theassistant controlling the tail end of the guidewire to keep it frommoving out of position or touching the floor or other non-sterile areas.The OTW techniques have been widely practiced and provide very goodtrackability for the devices along the guidewire. However, thesetechniques require that the long tail end of the guidewire be controlledat all times, requiring at least one additional assistant throughout theprocedure. Further, the threading of the entire length of the catheteralong the guidewire can be somewhat difficult and time consuming.Moreover, limiting the speed with which procedures can be completed andthe types of procedures that can be easily performed, these techniquesrequire each treatment device to be completely retracted along theguidewire before a further treatment device can be advanced along thesame guidewire to the treatment site.

The second common category of techniques for advancing treatmentapparatus to a treatment site is commonly referred to as “rapidexchange” techniques. In rapid exchange procedures a guidewire lumen isprovided over only a relatively short distal length of the treatmentcatheter, having a guidewire port exiting the catheter shaft next to ora short distance back from the treatment device. In this manner arelatively short guidewire can be employed that does not extend far fromthe patient's body. The physician advances the catheter over theguidewire (through the guidewire lumen) and gains control of theproximal end of the guidewire where it exits the catheter near thecatheter's distal end. The physician can then guide the catheter intoposition without the need of an assistant controlling an extra longguidewire tail. Examples of such devices are described in U.S. Pat. No.4,762,129 to Bonzel and U.S. Pat. No. 5,040,548 to Yock. Although therapid exchange techniques may sacrifice some trackability in use, thesetechniques can allow for faster threading of each treatment device andcost savings in the elimination of extra long guidewires and oneassistant to control the guidewire tail during the procedure. However,in practice these techniques also require each treatment device to becompletely retracted along the guidewire before a further treatmentimplement can be advanced along the guidewire to the treatment site.

Other apparatus have been developed to provide some of the same benefitsprovided by the rapid exchange catheter techniques. For example, it hasbeen suggested that the guidewire connect to the treatment catheter onlyat the distal tip of the guidewire, with a tube housing a guidewirelumen extending along the outside of the treatment device. Examples ofthese devices are described in U.S. Pat. No. 5,458,639 to Tsukashima etal. and U.S. Pat. No. 6,371,961 to Osborne et al. A similar device istaught in U.S. Pat. No. 6,394,995 to Solar et al. whereby an“advancement member” is provided attached to a treatment balloon; theadvancement member includes a short tube at its far distal end forming aguidewire lumen. While these devices may deliver some of the samebenefits of the conventional rapid exchange catheters, trackability maybe a far greater problem since the guidewire is attached to thetreatment catheter only at the very tip of the catheter. Additionally,depending upon the dimensions and stiffness of the tube housing theguidewire lumen (or, in the case of the Solar et al. device, of the“advancement member”), its presence on the outside of the treatmentdevice may interfere with the proper operation of the treatment device.Finally, as was true with the other techniques discussed above, thesedevices would appear to require each treatment device to be completelyretracted along the guidewire before a further treatment implement canbe advanced along the guidewire to the treatment site.

It is accordingly a purpose of the present invention to provide animproved apparatus for advancement of a catheter along a guidewire thatcan be loaded and operated on a relatively short guidewire by a singleoperator.

It is a further purpose of the present invention for such an apparatusto provide a guidewire lumen that affords all necessary trackabilitywhile a treatment device is being advanced to a treatment site.

It is still a further purpose of the present invention for such anapparatus to allow other treatment devices to be advanced along the sameguidewire without prior removal of the first treatment device.

These and other purposes of the present invention will become evidentfrom review of the following description.

SUMMARY OF THE INVENTION

The present invention is an improved catheter device that includes adisruptable guidewire channel. The guidewire channel is configured toprovide necessary trackability of the catheter along the guidewireduring introduction of the catheter to a treatment site. Once treatmentis completed, the guidewire channel can then be disrupted so as to freethe guidewire from the catheter in situ.

In one embodiment of the present invention, it comprises a balloon andcatheter assembly having an enlargeable balloon mounted on a cathetershaft. A sleeve is attached to the balloon forming a guidewire channelalong at least a portion of the balloon. At an appropriate time, thesleeve may be disrupted to cause a guidewire placed within the sleeve tofree from the balloon. The sleeve can be disrupted through a variety ofmeans, including being formed from intentionally fragile material thatwill separate upon inflation of the balloon, having one or moreseparation lines (for example, perforations) pre-formed in the sleeve,having an attachment line between the sleeve and the balloon that isformed to split at an appropriate time, and having one of a variety ofslots into which the guidewire can be placed and then remotely removed.

The present invention may be further defined as a guidewire deliverabletreatment implement comprising a sleeve attached to the implementforming a guidewire channel along at least a portion of the implement.Again, the sleeve is disruptable to cause a guidewire placed within thesleeve to free, in whole or in part, from the implement upon disruptionof the sleeve. Treatment implements that may be employed with thepresent invention may include: fluid-inflatable balloons; mechanicallyexpandable balloons; catheters; catheter systems; stent deliverysystems; stent-graft delivery systems; embolic filters; occluders; andother such devices.

The present invention may be still further defined as a medical devicehaving a balloon configured for insertion within a patient's bodydirected along a guidewire and a guidewire channel attached to theballoon. The guidewire channel is formed from a material that maintainsthe guidewire close to the balloon during insertion and alters uponinflation of the balloon to separate the guidewire from the balloon uponsubsequent deflation of the balloon. This separation of the guidewirefrom the balloon may take the form of various separation lines or othercomplete disruption means or may include a material that disrupts bydistending away from the balloon so as to allow other devices to beadvanced over the same guidewire past the balloon through the disruptedchannel.

The apparatus of the present invention provides distinct advantages overexisting over-the-wire and rapid exchange catheter introduction methods,including the ability to achieve much faster treatment implementexchanges, the ability to rapidly deliver multiple treatment implementsin series, and the ability to maintain multiple treatment implementssimultaneously at a treatment site using a single guidewire. Theseadvantages can be realized by the present invention because: thecatheter does not have to be axially removed prior to advancement ofanother catheter on the same guidewire; the catheter can remain acrossan initial lesion for future touch up, while another catheter isadvanced to treat a distal lesion; and the catheter allows treatment ofmultiple stenotic lesions at a bifurcation requiring only one guidewire,thus eliminating entanglement of guidewires that can occur whenutilizing multiple guidewires.

DESCRIPTION OF THE DRAWINGS

The operation of the present invention should become apparent from thefollowing description when considered in conjunction with theaccompanying drawings, in which:

FIG. 1 is an isometric view of a balloon catheter incorporating oneembodiment of a guidewire channel of the present invention;

FIG. 2 is cross-section view of the balloon catheter and a guidewirechannel along line 2-2 of FIG. 1;

FIG. 3 is an isometric view of the balloon catheter of FIG. 1, showingthe balloon fully inflated and the guidewire channel disrupted;

FIG. 4 is an isometric view of a balloon catheter incorporating aguidewire channel of the present invention with a stent mounted over theballoon catheter and guidewire channel;

FIG. 5 is an isometric view of the balloon catheter and stent of FIG. 4,showing the balloon and stent fully expanded and the guidewire channeldisrupted;

FIG. 6 is a side view of the balloon catheter and stent of FIG. 4positioned in a patient's body at the junction of two blood vesselsshown in cross-section;

FIG. 7 is a side view of the balloon catheter and stent positioned inthe blood vessel as shown in FIG. 6, showing the balloon and stent fullyexpanded;

FIG. 8 is a side view of the balloon catheter and stent positioned inthe blood vessel as shown in FIG. 7, showing the balloon catheterdeflated and the stent positioned fully expanded within the bloodvessel;

FIG. 9 is an isometric view of a second balloon catheter and stent beingadvanced along a guidewire following expansion of a first stent havingbeen deployed on the same guidewire;

FIG. 10 is an isometric view of a balloon catheter incorporating anotherembodiment of a guidewire channel of the present invention;

FIG. 11 is an isometric view of the balloon catheter of FIG. 10, showingthe balloon fully inflated and the guidewire channel disrupted;

FIG. 12 is an isometric view of a balloon catheter incorporating stillanother embodiment of a guidewire channel of the present invention;

FIG. 13 is an isometric view of the balloon catheter of FIG. 12, showingthe balloon fully inflated and the guidewire channel disrupted throughdistension;

FIG. 14 is an isometric view of the balloon catheter of FIG. 13, showingthe balloon deflated and the guidewire channel remaining disruptedthrough distension;

FIG. 15 is an isometric view of still another embodiment of the presentinvention comprising multiple separate guidewire channels;

FIG. 16 is an isometric view of another embodiment of a balloon catheterof the present invention, employing a guidewire channel along withcatheter tip including a guidewire centering groove;

FIG. 17 is an isometric view of the balloon catheter of FIG. 16, showingthe balloon fully inflated, the guidewire channel disrupted, and theguidewire separated from the centering groove in the catheter tip;

FIG. 18 is an isometric view of a further embodiment of a ballooncatheter of the present invention comprising a disruptable channelformed in the balloon itself and employing a catheter tip with aguidewire centering groove;

FIG. 19 is an isometric view of the embodiment of FIG. 18, showing theballoon fully inflated, releasing the guidewire from the channel formedin the balloon, and the guidewire separated from the centering groove inthe catheter tip;

FIG. 20 is an isometric view of the embodiment of FIG. 18 including astent mounted over the balloon;

FIG. 21 is an isometric view of a further embodiment of the presentinvention employing a guidewire channel on a mechanical balloon;

FIG. 22 is an isometric view of a still further embodiment of thepresent invention employing a guidewire channel with perforated tearrelease;

FIG. 23 is an isometric view of another further embodiment of thepresent invention employing a guidewire channel with a slit release;

FIG. 24 is an isometric view of still another embodiment of the presentinvention employing a guidewire channel that has a slot allowing forrotational release;

FIG. 25 is a side view of a stent placement in a branched vesselfollowing the procedure illustrated in FIGS. 6 through 8 with theguidewire repositioned into the branch vessel through the interstices ofthe stent;

FIG. 26 is a side view of the stent placement of FIG. 25 showing asecond balloon catheter of the present invention being advanced alongthe guidewire;

FIG. 27 is a side view of the stent placement of FIG. 26 showing thestent and balloon catheter positioned within the branch vessel;

FIG. 28 is a side view of the stent placement of FIG. 27 showing thestent and balloon catheter fully inflated within the branch vessel;

FIG. 29 is a side view of the stent placement of FIG. 28 showing boththe balloon in the main vessel and the balloon in the side vessel fullyinflated;

FIG. 30 is an isometric view of another embodiment of the presentinvention comprising a further example of a disruptable channel formedfrom the external surface of the balloon itself, having a guidewireretainer within the balloon, and employing a catheter tip with aguidewire centering groove;

FIG. 31 is an isometric view of the embodiment of FIG. 18, showing theballoon fully inflated, releasing the guidewire from the channel formedin the balloon, and the guidewire separated from the centering groove inthe catheter tip;

FIG. 32 is a cross section view along line 32-32 of FIG. 30;

FIG. 33 is a cross section view along line 33-33 of FIG. 31;

FIG. 34 is an isometric view of one embodiment of a guidewire retainerfor use in the embodiments of FIGS. 30 through 33;

FIG. 35 is an isometric view of another embodiment of a guidewireretainer for use in the embodiments of FIGS. 30 through 33;

FIG. 36 is an isometric view of still another embodiment of the presentinvention comprising another example of a disruptable channel formed inthe balloon itself, having a guidewire retainer placed within theballoon, employing a catheter tip with a guidewire centering groove, andemploying a disruptable channel in the catheter tube proximal to theballoon;

FIG. 37 is an isometric view of the embodiment of FIG. 18, showing theballoon fully inflated, releasing the guidewire from each of theballoon, the centering groove in the catheter tip, and the disruptablechannel in the catheter tube;

FIG. 38 is a cross section view along line 38-38 of FIG. 36;

FIG. 39 is a cross section view along line 39-39 of FIG. 37;

FIG. 40 is an isometric view of a further embodiment of a catheterincluding a disruptable channel of the present invention;

FIG. 41 is a side view of yet another guidewire channel of the presentinvention wherein the guidewire channel is formed in the wall of theballoon;

FIG. 42 is a cross section view along line A-A of FIG. 41 showing oneembodiment of a guidewire channel that can be formed in the wall of theballoon;

FIG. 43 is an enlarged sectional view of the guidewire channel of FIG.42;

FIG. 44 is a cross section view along line A-A of FIG. 41 showinganother embodiment of a guidewire channel that can be formed in the wallof the balloon;

FIG. 45 is an enlarged sectional view of the guidewire channel of FIG.44;

FIG. 46 is a cross section view along line A-A of FIG. 41 showing stillanother embodiment of a guidewire channel that can be formed in the wallof the balloon;

FIG. 47 is an enlarged sectional view of the guidewire channel of FIG.46; and

FIG. 48 is a longitudinal cross-section of a balloon-on-a-wire deviceaccording to an aspect of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is an improved apparatus for delivery of aninterventional device along a guidewire to a remote treatment site in apatient's body.

As the terms “interventional” or “minimally invasive” devices orprocedures are used herein they are intended to encompass any device orprocedure whereby a medical treatment implement is delivered to atreatment site by use of wires and/or tubes threaded through vessels orother body passageways accessed remotely. Such devices may include thoseemployed in: balloon angioplasty; thrombectomy; stent, graft, orstent-graft placement; embolic filter device placement; remotediagnostic procedures, such as those employing fiber optic cameras,ultrasound monitoring, MRI monitoring, x-ray monitoring, etc.; remotetherapeutic procedures, such as those employing cutting blades, lasers,heat application, cold application, radiation, drug delivery, etc.; andany other similar devices or procedures now known or later developed.Currently such interventional procedures are employed in large and smallblood vessels, in other vessels in the body, such as in the bile duct,as well as in the respiratory, digestive, reproductive, and other bodysystems. As the term “patient” is used herein it is intended toencompass both humans and animals.

As the term “guidewire” is used herein it is intended to encompass anydevice that provides a track for guiding medical implements to atreatment site in a minimally invasive procedure. Such devices mayinclude straight, coiled, braided, coated, or other forms of wires,various tubular devices, such as catheter tubes, hypo-tubes,balloon-on-wire devices, and the like, or any other form of similarelongated device.

Referring to the illustrations, FIGS. 1 and 2 show one embodiment of aguidewire channel 30 of the present invention. The guidewire channel 30comprises a sleeve 32 attached to a treatment implement 34, in this casean expandable balloon 34, mounted on a catheter shaft 36. The cathetershaft 36 includes a distal end 38 and a proximal end (not shown)extending out of the patient's body. The guidewire channel 30 isproportioned to slidably receive a guidewire 40 therein. The cathetershaft 36 should be stiff enough to allow the balloon 34 to be advancedalong the guidewire 40 by the physician pushing on that portion of thecatheter shaft 36 extending outside of the patient's body.

If the catheter tube alone does not provide sufficient longitudinalstiffness, a reinforcement wire 41 or similar support member may beincorporated into the catheter shaft 36 to aid in its pushability. Thesupport member can be combined with the catheter in a variety of ways,including being attached distally to the catheter shaft distal to theballoon, being attached to the catheter shaft proximal to the balloon,or being unattached to the catheter shaft distally. In an unattachedconfiguration, the support member can provide pushability when held bycompressive forces of a stent mounted over the guidewire or similarconstraining means. The support member can be attached proximally, suchas to the catheter shaft or the hub.

It is important that the treatment implement tracks closely along theguidewire while the catheter is being advanced to a treatment site in abody. This is particularly important when a treatment site is in smallvessels, such as coronary arteries, that may have numerous branchvessels located nearby. As such, the guidewire channel should beproportioned to keep the treatment implement closely aligned with theguidewire during device advancement through the body while not overlyconstricting movement of the treatment implement along the guidewire.However, the present inventor has realized that once the treatmentimplement is correctly positioned within the treatment site andtreatment has occurred, there is no reason why the treatment implementmust remain on the guidewire for its subsequent removal from the body.

As such, the guidewire channel 30 of the present invention includesmeans to “disrupt” the channel at an appropriate time so as to separatethe treatment implement 34 from the guidewire 40. In the embodimentillustrated in FIGS. 1 and 2, such means 42 comprises a separation linecomprising a line of perforations formed along the length of the sleeve32. As is shown in FIG. 3, when the balloon 34 is expanded, the sleeve32 disrupts along the separation line, freeing the guidewire 40 from theconstraint of the guidewire channel. The sleeve 32 can occupy all or aportion of the balloon circumference.

In this manner, the guidewire channel 30 provides the necessary guidancewhile the treatment implement is being advanced into the body, buteffectively disappears when guidance is no longer required so that thetreatment implement can be removed independently of the guidewire.Unlike previous interfaces between catheters and guidewires, in situseparation of a first treatment implement from the guidewire immediatelymakes the guidewire available for the advancement of further treatmentimplements to the treatment site or to another adjacent or distaltreatment site. This provides the physician with numerous options thatare not currently available, such as allowing a second treatmentimplement to be advanced along the guidewire while a first treatmentimplement is either left in place or is being simultaneously removed,and/or allowing multiple treatment implements to be mounted in series ona single guidewire, with each advanced and used without the need toimmediately and completely remove the previous treatment device.

It should be evident that this construction circumvents the need for along guidewire and extra medical personnel required with OTW catheters,while permitting far easier and quicker catheter exchanges than arepossible with current so-called “rapid exchange” catheter systems.

For most embodiments of the present invention, the sleeve 32 should beformed from a relatively thin material that is selected and/or treatedto disrupt at the appropriate time upon inflation of the balloon 34. Asleeve of the present invention may be constructed from a wide varietyof materials, including PTFE, expanded PTFE, polyamide, polyether blockcopolymers and other copolymers, polyurethane, ethylene vinyl acetate(EVA), polyvinylchloride (PVC), poly(ethylene terephthalate) (PET),PETG, polyethylene, silicone, latex, etc., as well as composites orvarious combinations thereof. The sleeve can be attached to virtuallyany form of balloon material, including balloons made from any of theabove listed materials. The balloon material may be elastic orinelastic, and compliant, non-compliant, or semi-compliant. One suitableballoon material that may be used with the present invention comprises acomposite balloon of expanded PTFE and elastomer, such as the balloonsdescribed in U.S. Pat. Nos. 5,752,934, 5,868,704, 6,120,477, all toCampbell et al.

Attachment of the sleeve to the balloon may take any suitable form, suchas through adhesive, heat welding, ultrasonic welding, or other bondingmethod. The sleeve material should be thermally compatible with theballoon material if heat bonding is the means of attachment. Thepreferred sleeve material should have minimal thickness of less thanabout 0.003 inches (about 0.08 mm), and more preferably a thickness ofbetween about 0.001 to about 0.002 inches (about 0.02 to 0.05 mm). Aminimal thickness of the sleeve is preferred in that it is desirablethat the guidewire channel not interfere with the normal operation ofthe treatment implements.

As the term “sleeve” is used herein, it is intended to encompass anyconfiguration of material that forms a channel through which a guidewirewill be retained in close proximity to a catheter shaft during deviceadvancement through a body while allowing the catheter shaft to sliderelative to the guidewire. A sleeve of the present invention maycomprise one or more strips of material that is attached to a balloon orother treatment implement, or it may comprise one or more tubes ofmaterial that surrounds the balloon or other treatment implement, or itmay comprise a guidewire retainer inside a balloon. Regardless ofconfiguration, the sleeve of the present invention should provide aguidewire channel that is “disruptable.”

As is explained and illustrated in greater detail below, as the terms“disrupt” or “disruptable” are used in reference to the guidewirechannels of the present invention they are intended to encompass anyguidewire channel that breaks, separates, distends, or otherwisereleases the guidewire from a treatment implement to allow anothertreatment implement to be advanced along the same guidewire withoutremoval of the prior treatment implement. Disruptable guidewire channelsof the present invention may include ones that are attached to theballoon material, integral with the balloon material, or folded withinthe balloon material.

FIGS. 4 and 5 illustrate how the above-described device may be used todeliver a deployable device, such as a stent. As is shown in FIG. 4, astent 44 may be mounted over the previously described balloon 34 andguidewire channel 30 of the present invention. In this embodiment theguidewire 40 passes through the guidewire channel 30 under the stent 44.FIG. 5 shows that upon inflation of the balloon 34, the stent 44 willexpand to its deployed diameter while the guidewire channel 30 disruptsbeneath the stent 44. Once the balloon 34 is deflated, the guidewire 40will be separated from the balloon, allowing removal of the catheter 36independent of the guidewire.

FIGS. 6 through 8 demonstrate the procedure for deploying the constructof FIGS. 4 and 5 in a blood vessel. FIG. 6 shows the balloon catheter 36(incorporating the guidewire channel 30 of the present invention) andstent 44 of FIG. 4 positioned in a patient's body at the junction of amain vessel 46 and a branch vessel 48. FIG. 7 shows the balloon 34 andstent 44 fully expanded in the main vessel 46, with the guidewirechannel 30 disrupted underneath the stent 44. FIG. 8 shows the balloon34 fully deflated and the stent 44 positioned fully expanded within themain vessel 46. The guidewire 40 is now completely separated from theballoon 34 and catheter 36.

Once the guidewire 40 is separated from the balloon 34, additionaldevices can then be advanced on the guidewire 40 in order to accomplishfurther treatments. For example, FIG. 9 shows a second balloon 34 bdevice of the present invention being advanced over the guidewire 40with the original balloon device 34 a left in place to accomplishfurther treatments. In this instance, two stents 44 a, 44 b may bedeployed end-to-end (or overlapping) to address an extended defect in avessel, with both balloons 34 a, 34 b kept in their original deploymentpositions to facilitate final “touch up” of stent placement prior toremoval of the balloons.

In another embodiment of the present invention, a second stent can beadvanced even further distal to the first stent in order to treatanother defect. This problem can present itself when fluoroscopy failsto detect the second distal defect prior to treatment of the firstdefect. Maintaining the first implement across the first defect allowssubsequent treatment (for instance, further distension of the firststent) to occur after treating the second distal defect.

A further embodiment of the present invention is shown in FIGS. 10 and11. In this embodiment the guidewire channel 30 is formed from a sleeve32 that has a separation line comprising an intentionally looseattachment line 50 to the balloon 34. When the balloon is inflated, asis shown in FIG. 11, the loose attachment line 50 will separate from theballoon 34, freeing the guidewire 40. Loose attachment of the sleeve 32to the balloon 34 may be accomplished through a variety of means,including use of weak adhesive, discontinuously applied adhesion points,perforations, weak sleeve material along the attachment line, weak weld(e.g., weak heat bond), etc.

A further variation on the present invention is illustrated in FIGS. 12through 14. In this embodiment the guidewire channel 30 comprises asleeve 32 of distensible material that expands along with the balloon 34and then has little or no recoil to its original dimensions followingballoon 34 deflation. Although this configuration does not completelyseparate the guidewire 40 from the guidewire channel 30 followingdeployment, the guidewire channel 30 is still disrupted in that otherdevices can be advanced past the deflated first balloon 34 through thedistended sleeve material. Suitable distensible material for use in thisembodiment may include any material that can be distended beyond itselastic limit so as to present permanent plastic deformation.

A further embodiment of the present invention is shown in FIG. 15. Inthis embodiment, multiple separate guidewire channels 30 a, 30 b areattached to the treatment implement 34. Each of the guidewire channels30 a, 30 b may include one or more of the previously describeddisruption means so as to free the guidewire 40 from the treatmentimplement 34 at the appropriate time. This embodiment may be preferableunder certain circumstances where it is desirable to further limit theamount of material comprising the guidewire channel. It should beevident that this embodiment may be practiced with two, three, four,five, or more separate guidewire channels 30. Additionally, it should beunderstood that the separate guidewire channels of this embodiment maybe of dimensions and properties identical to each other, or may differfrom each other in dimensions, materials, attachment means, disruptionmeans, and/or other properties.

FIGS. 16 and 17 illustrate another embodiment of the present inventionthat employs both a disruptable guidewire channel 30 attached to thetreatment implement 34 and a unique catheter tip 56. The disruptableguidewire channel 30 may be of any other forms described herein. Thecatheter tip 56 includes a guidewire centering groove 58 therein that isadapted to receive and retain a guidewire 40 in sliding fit duringdevice loading and advancement to a treatment site. The centering groove58 provides an additional anchorage for the guidewire to the treatmentimplement during device advancement and may be used to improve thetrackability and crossability of the device. The centering groove 58 isproportioned to release the guidewire 40 from the tip 56 when thetreatment implement 34 is expanded, as is shown in FIG. 17. Preferablythe tip 56 and centering groove 58 are formed from the same or similarmaterial as the balloon or catheter shaft material, such asthermoplastic material used in medical devices (e.g., polyamide,polyurethane, PTFE, polyethylene, EVA, PVC, etc.).

A similar application of the present invention is shown in FIG. 18. Inthis embodiment, a disruptable channel 60 is formed from the externalsurface of the balloon 34 itself. Again, a tip 56 with a centeringgroove 58 is employed to aid in guidewire 40 attachment, trackabilityand crossability during device advancement. As is shown in FIG. 19, whenthe balloon 34 is expanded, the disruptable channel 60 disappears,releasing the guidewire 40 from attachment to the balloon 34. Theguidewire 40 will likewise separate from the centering groove 58.

FIG. 20 illustrates how the embodiment of FIGS. 18 and 19 can be used todeliver a deployable device 44. The disruptable channel 60 should beformed of sufficient dimensions and structural integrity so that thedeployable device 44 can be adequately attached to the balloon 34without hindering the proper sliding motion of the guidewire 40 throughthe disruptable channel 60 during device advancement.

FIG. 21 shows how the present invention may be adapted to be used withother treatment apparatus beyond inflatable balloons. In thisembodiment, a guidewire channel 30 of the present invention is attachedto a mechanical expansion device 62, adapted to expand upon mechanicalactuation instead of introduction of fluid pressure. Other treatmentimplements that may benefit from use with a guidewire channel of thepresent invention may include, without limitation: otherfluid-inflatable balloons; mechanically expandable balloons; catheters;catheter systems; stent delivery systems; stent-graft delivery systems;embolic filters; occluders; and other such devices.

FIGS. 22 through 24 illustrate embodiments of the present invention thatcan release from the guidewire without need for an inflation device todisrupt the sleeve.

FIG. 22 demonstrates that the guidewire channel 30 of the presentinvention may be formed from a tubular sleeve 32 that completelysurrounds the treatment implement 34 and includes a tear line 42. Inthis embodiment, the sleeve is slidable relative to a coaxial underlyingcatheter shaft 36 (for instance, the tubular sleeve 32 may extend alongthe entire length of the catheter 36 to allow the sleeve and thecatheter to be moved relative to one another). If an inflatable memberis not employed, an enlarged bulb member 63 can be mounted on thecatheter shaft 36. By actuating the catheter shaft 36 relative to thetubular sleeve 32 (by either pulling the catheter or pushing the tubularsleeve, or both), the bulb member 63 can disrupt the tear line 42,freeing the guidewire 40 from the guidewire channel 30. Additionally,this embodiment further demonstrates that the guidewire 40 does not haveto traverse the entire length of the sleeve 32, but may be adapted toexit the sleeve 32 through a port 64 provided along its length. In thismanner, the sleeve 32 does not have to tear along its entire length inorder to release the guidewire 40.

FIG. 23 illustrates another disruption means for use with the presentinvention. In this embodiment the guidewire channel 30 comprises atubular sleeve 32 formed from a resilient material with a resealableslit 68 and an exit port 70. An inner member contains a groove orpassageway 66 extending from the distal tip and terminating at an outermember exit port 70. A guidewire 40 is fed through the passageway 66 atthe time of device introduction. At the time of deployment, theresilient material of the sleeve 32 will part along the slit 68,releasing the guidewire from the passageway 66. Proximal displacement(pulling) of the outer member, or distal displacement (pushing) of theinner member, or some combination of the two, will release theguidewire.

Still another embodiment of the present invention is shown in FIG. 24.In this embodiment, the guidewire channel 30 is formed from a sleeve 32having a rotational slot 72 formed therein. The guidewire 40 can bemounted into the channel by threading it through the sleeve 32 within agroove 75 of the inner member and out port 74, or by positioning theguidewire 40 along the length of the slot 72 and then pressing theguidewire 40 into the slot while the sleeve 32 is rotated to align theguidewire 40 within the sleeve 32 and exit the sleeve 32 through port74. The sleeve 32 in this embodiment may be formed from a disruptablematerial, as previously described, or the guidewire can be released fromthe guidewire channel 30 by rotating the sleeve 32 at the appropriatetime to align the groove 75 with the slot 72 and allow the guidewire to“pop” free from the slot 72.

Embodiments of the present invention that can be utilized without aballoon, such as those illustrated in FIGS. 22 through 24, have numerouspossible applications, including without limitation, use withself-expanding stents, embolic filter devices, septal defect occlusiondevices, etc.

As has been noted, among the advantages of the present invention is thefact that a physician is provided with unique treatment options notpresently available using conventional catheter delivery devices. Onesuch unique procedure is illustrates in FIGS. 25 through 29. FIG. 25shows the stent placement in a main vessel 46 illustrated in FIGS. 6through 8, with the balloon 34 left in place as shown in FIG. 8. If aphysician would now like to likewise provide a stent in the branchvessel 48, under currently available procedures s/he would have toeither remove the first balloon 34 and then direct a second deploymentdevice down the same guidewire 40, or laboriously thread a secondguidewire into the branch vessel 48.

With the present invention, however, since the guidewire 40 has beenreleased from the balloon 34 in the procedure described in FIGS. 6through 8, the guidewire 40 is now free to be repositioned into thebranch vessel 48, as is illustrated in FIG. 25, while leaving theballoon 34 in position within the main vessel 46. A second deploymentapparatus 76 can then be advanced along the guidewire 40, as is shown inFIG. 26, and positioned into the branch vessel 48, as is shown in FIG.27.

Once the deployment apparatus 76 is properly positioned in the branchvessel 48, a second stent 78 can then be deployed, as is shown in FIG.28. Since the first balloon 34 did not have to be removed to allowintroduction of the second deployment apparatus 76, the physician thenhas the option of immediately reinflating the first balloon 34, as isshown in FIG. 29, in order to make sure both stents 44, 78 are fully andproperly deployed in the two vessels 46, 48. The ability to performsimultaneous ballooning of both of these stents using a single guidewireis believed to be particularly unique to the present invention. Thisallows this procedure to be completed faster and more efficiently thanin any previously available stent deployment method.

Still further embodiments of the present invention are illustrated inFIGS. 30 through 47.

FIGS. 30 through 34 illustrate an embodiment of the present inventionthat improves on the embodiment illustrated in FIGS. 18 and 19. As waspreviously described, a disruptable guidewire channel 60 can be formedfrom the external surface of the balloon 34 itself. In this embodiment,a flexible guidewire retainer 80 is contained within the balloon 34 toaid in holding the guidewire 40 within the guidewire channel 60. Whenthe balloon 34 is inflated, as is shown in FIGS. 31 and 33, the balloon34 applies an outward force that causes the guidewire retainer 80 toflex open releasing the portion of the balloon contained within theguidewire retainer, therefore releasing the guidewire 40. The centeringgroove in the tip could be a continuation of the guidewire retainerinside the balloon or attached thereto. The guidewire retainer insidethe balloon could be a continuation of the support member or attachedthereto. The guidewire retainer could also be a continuation of theinflation lumen or attached thereto. The support member could beintegral to the guidewire retainer. An indentation 82 can be formed inthe catheter shaft 36 to assist in the transition of the guidewire intothe guidewire channel 60.

One embodiment of a guidewire retainer 80 is shown in FIG. 34. Theguidewire retainer 80 comprises a cylinder with at least a semi-circularcross section.

The retainer may comprise any form that provides some gripping of theguidewire, including a tube having a longitudinal slice down its lengthto the more longitudinally slotted constructions of FIGS. 34 and 35. Oneor more slits 84 can be provided in the retainer 80 to aid in itsflexibility and adjust the pressure necessary to release the guidewireand a portion of the balloon from the retainer. The guidewire retainer80 can be constructed from any suitably flexible and resilient material,including various plastics or metals. FIG. 35 illustrates that the widthof the slits 84 in the guidewire retainer 80 can be altered to aid inits flexibility, adjust the release properties of the retainer relativeto the particular materials used to create the retainer, as well asadjust the operating parameters of the balloon. It should be evidentfrom this description that the shape, form, materials, and number of theguidewire retainer(s) 80 used in any given application of the presentinvention may take a wide variety of forms.

This embodiment of the present invention may be further improved byproviding releasable retention means in the catheter proximal to theballoon, as is illustrated in FIGS. 36 through 39. As is shown, achannel 86 is provided in the catheter 36 proximal to the balloon 34that is disruptable. The channel comprises a longitudinal slit 88 in thecatheter shaft and an guidewire port 90. This proximal attachment of theguidewire 40 may be beneficial in tracking the balloon into place in thebody. The channel 86 may be any suitable length, including a length ofless than 5 cm to 25 cm or more from the balloon. When the balloon isinflated, as is shown in FIG. 37, the guidewire 40 will actuate out ofthe disruptable channel 86 to become completely free from the balloon 34and catheter 36. In certain applications (e.g., when a longerdisruptable channels 86 is employed), it may be desirable to include acollapsible inflation lumen 92, as shown in FIG. 38 that will inflatewhen pressure is applied to the balloon. As is shown in FIG. 39, whenthe collapsible lumen 92 is inflated, the collapsible lumen 92 will fillthe catheter shaft 36 to force the guidewire 40 out of the channel 86.

FIG. 40 illustrates another embodiment of the present invention whereinthe catheter shaft 36 includes a peelable sheath 94 covering theguidewire channel 96. The sheath 94 is disruptably attached to thecatheter shaft 36, such as through use of perforation lines 98 a, 98 b.An actuation cord 100 is attached to one end of the sheath 94. In thisembodiment the guidewire channel 96 can be disrupted at any desired timesimply by pulling on the actuation cord 100 to remove the sheath 94 andfree the guidewire 40.

Other versions of the present invention are shown in FIGS. 41 through47. In these embodiments, a guidewire channel 102 is formed in the wall104 of the balloon 34. As is shown in FIGS. 42 and 43, the guidewirechannel 102 may be integral with the balloon itself, with the lamina ofthe balloon wall 104 fully surrounding the channel 102. FIGS. 44 and 45demonstrate that the guidewire channel 102 may alternatively comprise ininvagination 106 formed into the balloon wall. The invagination 106 mayinclude a cover 108 to assist in maintaining the guidewire 40 within thechannel 102. FIGS. 46 and 47 illustrate that the guidewire channel 102may comprise a separate component 110 that is attached to the balloon34, such as through use of an adhesive or a cover 112. One skilled inthe art will appreciate that similar constructs can be achieve throughother means including direct extrusion of the balloon material.Likewise, one skilled in the art will further appreciate that one ormore such channels 102 may be provided in any given balloon and/or asingle relatively wide channel can be provided in the balloon to allowpassage of multiple guidewires.

In a further aspect of the invention, either or both of the catheterassembly and the guidewire can be a balloon-on-wire device comprising alongitudinally extending wire having a length, an outer surface, aproximal end, a distal end, and an expandable balloon having an interiorspace, the balloon being located at the distal end of the wire. In afurther aspect of the invention the longitudinally extending wirecomprises a lumen defined by an inner surface of the wire and extendingfrom the proximal end of the wire to the distal end and being incommunication with the interior space of the balloon. Inflation fluidcan be delivered to the interior space of the balloon via the lumen.Moreover, the outer surface of the wire can further comprise at leastone cut therein. In a further aspect of the invention the longitudinallyextending wire is provided with polymer film covering at least a portionof the outer and/or inner surface thereof. The device further includes adisruptable guidewire channel, as discussed in detail above.

The longitudinally extending wire can be any suitable material such asmetal or polymer and includes, for example, tubular structures such aspolymer tubes, metal tubes (e.g., hypotubes), stranded wires, braidedwires, etc.

In yet a further aspect of the invention, the at least one cut in theouter surface of the wire can extend from the outer surface to the innersurface. The at least one cut may be a spirally extending cut extendingfor any desirable length of the wire. In an aspect of the invention, thespirally extending cut can extend from the proximal end to the distalend of the wire. Moreover, the pitch of the spiral cut can be variedfrom one point to a second point along the length of the wire to varythe flexibility of the wire over a desired length of the wire.

In an aspect of the invention, the polymer film can be provided as apolymer film wrap. In a further aspect of the invention, the polymerfilm can be provided as a tubular shrink wrap. With regard to thepolymer film wrap, in an aspect of the invention, the polymer film wrapis provided as a helical wrap. Moreover, in an aspect of the invention,the polymer film wrap comprises porous expanded polytetrafluoroethylene(“ePTFE”). Exemplary films and methods of film wrapping are disclosed incommonly owned and copening U.S. Patent Application Publication Number2005/0059957, the subject matter of which is herein incorporated byreference.

Suitable polymer films include, for example, flexible polymer materialssuch as polyethylene, including ultra-high molecular weightpolyethylene, polypropylene, polyamide, polyethylene terephthalate,fluorinated ethylene propylene (FEP), perfluoro alkoxy resin (PFA),polyurethane, polyester, polyimide, etc. Porous polymers, optionallyprovided with a thin, non-porous coating, may be advantageously usedbecause of their excellent flexibility. The polymer film is mostpreferably made from a thin, ePTFE film that has been provided with aporous or non-porous coating of a thermoplastic such as a thermoplasticfluoropolymer, preferably fluorinated ethylene propylene (FEP). EPTFEfilms can be made as taught by U.S. Pat. Nos. 3,953,566 and 4,187,390 toGore and U.S. Pat. No. 5,476,589 to Bacino. It may be desirable tomodify the polymer film material by providing various fillers to thefilm. In the case of porous polymers such as ePTFE film, fillers can beimbibed into the porosity of the film by known methods, such as taughtby U.S. Pat. No. 5,879,794, to Korleski. Suitable fillers include, forexample, fillers in particulate and/or fiber form and can be ceramics,metals, metalloids, carbon, and combinations thereof. Particularlyuseful fillers include, for example, radiopaque materials, such as, forexample, gold, barium sulfate, bismuth subcarbonate, tungsten, andtantalum. The fillers can be used in combination with desired adhesivematerials when imbibed into the porosity of the polymer film. It mayalso be desirable to metalize the film on at least a portion thereof.Moreover, ePTFE/FEP laminate films are taught in U.S. Pat. No.6,159,565, to Campbell et al. In an aspect of the invention, the polymerfilm is provided in a helically-wrapped fashion. In a further aspect ofthe invention, polymer films which exhibit longitudinal shrinkage (e.g.,by heat or chemical activation) may be particularly attractive for usein certain aspects of the invention. Further suitable polymer films canbe polymer tubes which may be heat shrinkable materials. One suchmaterial is PET shrink tubing, which can be provided in very thin (e.g.,0.5 mil) thicknesses. ePTFE is another example of polymer film (ortubing) that may exhibit shrinkage upon either chemical or heatactivation.

It may be desirable to provide a suitable adhesive material to at leasta portion of at least one side of the polymer film. Any number ofadhesives may be useful according to this aspect of the invention;including thermoplastic adhesives, thermoset adhesives, pressuresensitive adhesives, heat activated adhesives, chemically activatedadhesives, and UV-curable adhesives, depending upon the particularembodiment and desired results. The adhesives can be provided in liquidor solid form. In an aspect of the invention, adhesives include, forexample, polyamides, polyacrylamides, polyesters, polyolefins (e.g.,polyethylene), polyurethanes, and the like.

With regard to film wrapping of cut wire, it is believed that anePTFE/adhesive laminate film may be particularly useful. For example, itmay be desirable to provide an adhesive to the outer surface, the innersurface, or both, of the ePTFE film to provide for enhanced properties.In such a case, it is believed that the ePTFE is particularlyattractive, since the ePTFE may act as a stable scaffold (i.e., the filmtends to shrink only a small amount) for the adhesive. For example, whenwrapping a metal hypotube with an ePTFE/FEP system, the FEP could act asan adhesive, the system could be heated to cause the FEP to flow;however, the FEP will tend to stay in the ePTFE structure and notinfiltrate into the fenestrations in the hypotube. Further embodimentscould include wrapping a cut PEBAX tube with an ePTFE film and anadhesive with a lower melting temperature—or indeed a UV curableadhesive.

FIG. 48 is a longitudinal cross-sectional view of an exemplaryballoon-on-a-wire device of the present invention comprising a spiralcut wire 201 (e.g., a metal tube such as hypotube) wrapped with a filmlayer 202. The cuts 203 in the wire 201 are essentially sealed by thefilm wrap 202. The desired flexibility of the wire 201 is maintained andby the addition of the film wrap 202, a sealed fluid lumen 204 is formedwithin the wire. Near the distal end of the device 200 is expandableballoon 205 having an interior 206. The balloon interior 206 is incommunication with lumen 204 via port 207. The device will furtherinclude a disruptable guidewire channel (not shown), as discussed above.Moreover, the wire 201 can be provided with a spiral cut with changingpitch across all, or a part of, the length of the wire, thus providing aflexibility transition region in the wire. Of course, desirable flexiblewire can be obtained by other means than providing a spiral cut wire. Inthis regard any longitudinally extending wire having at least one cut inits outer surface or through its wall may be used. Any desirable numberof cuts can be provided. For example, strategically placed cuts could belocated at any number of locations along the length and/or around thecircumference of the wire. The cuts in the wire could be strategicallyarranged to provide for varying flexibility across the length of thewire.

In a further aspect of the invention, a stent or stent-graft (not shown)can be mounted over the expandable balloon 205.

It is also possible to provide at least one radiopaque material to thedevice. The radiopaque material can be any suitable material and can belocated at any desired point along the length of the device.

The device may further comprise a stiffening device, which may belocated in the at least one lumen. In an aspect of the invention, thestiffening device is capable of being moved proximally and distally inthe at least one lumen. Suitable stiffening devices include, forexample, stylets, wires, tubes, braids, and combinations thereof. Thestiffening device may be solid or hollow. Moreover, the stiffeningdevice can have a variable stiffness along at least a portion of itslength. Further, the stiffening device may comprise any suitablematerial, such as, metal, metalloids, and polymers.

It should be noted that the inner surface or the outer surface of thewire can be pretreated (i.e., chemically etched, etc.) prior toproviding the polymer film or covering to the surface.

With respect to virtually all of the embodiments of the presentinvention, an additional benefit may be realized by the fact that theguidewire is positioned on the outside of the balloon. It is theorizedthat it can be beneficial under certain circumstances not to evenlyballoon a plaque occlusion in a blood vessel. By applying a focusedforce at distinct areas around the circumference of the vessel duringballooning, it is believed that the plaque may more successfully bedisrupted. Where focusing of expansion forces is desired, the presenceof the guidewire on the outside of the balloon may provide a ready meansto accomplish improved plaque treatment. In such instances it may bedesirable to provide radiopaque markers on the guidewire channel to aidin positioning the balloon and guidewire and effectuating focusedballooning.

Without intending to limit the scope of the present invention, thefollowing example illustrates how the present invention may be made andused.

EXAMPLE

One embodiment of the present invention can be constructed by modifyinga commercially available balloon catheter device.

A 4.0 mm×30 mm RX GEMINI Coronary Balloon Dilatation Catheter availablefrom Guidant/ACS of Santa Clara, Calif., may be used as the startingcatheter device and is modified in the following manner:

1. Insert a 0.36 mm diameter stainless steel wire in the tip and advanceit proximally until it exits the RX port.

2. Measure the distance from the tip to RX port.

3. Remove and cut the 0.36 mm wire to the measured length.

4. Reinsert the 0.36 mm wire. Use the EFD dispensing tip to wick Loctite4014 into the proximal RX channel and at the distal tip to secure the0.36 mm wire.

5. A sleeve of the present invention is cut from a film or tube ofexpanded PTFE having the following dimensions: not longer than theballoon, but long enough to provide optimal trackability; the widthshould be at least as wide as the diameter of the guidewire andsufficient to attach across enough of the balloon so that the sleevewill disrupt when the balloon is inflated.

6. Perforations are formed in the sleeve by holes 0.64 mm in diameter on1.02 mm centers along the entire length of the sleeve cutting using aCO₂ laser.

7. The sleeve is permanently attached to the Guidant/ACS balloon by anysuitable fashion, preferably adhesive such as Loctite 4014cyanoacrylate.

8. Apply a bead of adhesive along the length of the balloon.

9. Place one side of the sleeve lengthwise onto the bead of adhesive,securing the sleeve to the balloon, ensuring that the other side of thesleeve is free.

10. Place an appropriate sized mandrel for the proper guidewire sizealong the balloon and under the sleeve flap.

11. Apply a bead of adhesive onto the balloon at an appropriate locationto secure the free end of the sleeve. Wrap the sleeve over the mandreland onto the adhesive bead, securing the sleeve to the balloon andcreating a space to accommodate a future guidewire.

A balloon catheter device of the present invention is created throughthis above described process. The catheter includes a guidewire channelattached to the exterior of the balloon that is disruptable uponinflation of the balloon so as to free the guidewire from the guidewirechannel.

While particular embodiments of the present invention have beenillustrated and described herein, the present invention should not belimited to such illustrations and descriptions. It should be apparentthat changes and modifications may be incorporated and embodied as partof the present invention within the scope of the following claims.

1. A balloon-on-a-wire device comprising: an elongated wire having alength, an outer surface with at least one cut therein, polymer filmcovering at least a portion of the outer surface, a proximal end, and adistal end; an expandable balloon at the distal end of the wire; asleeve consisting of a strip of material attached to a portion of anouter surface of the balloon, forming a guidewire channel along at leasta portion of the expandable balloon; wherein the sleeve is disruptableto cause a guidewire placed between the strip of material and the outersurface of the balloon to release from the expandable balloon when thesleeve is disrupted and wherein the expandable balloon has a compacteddimension and an expanded dimension; a guidewire is located within theguidewire channel; the strip of material includes a separation line; andthe strip of material is disrupted by parting along the separation linewhen the expandable balloon is expanded, separating the guidewire fromthe balloon.
 2. The device of claim 1, wherein the separation linecomprises a line of perforations formed in the strip of material.
 3. Thedevice of claim 1, wherein the separation line comprises an attachmentline between the expandable balloon and the sleeve.
 4. The device ofclaim 1, wherein the guidewire is a balloon-on-a-wire device.
 5. Thedevice of claim 1, wherein the polymer film is a film wrap.
 6. Thedevice of claim 5, wherein the polymer film comprises ePTFE.
 7. Thedevice of claim 1, wherein the polymer film comprises tubular shrinkwrap.
 8. The device of claim 6, wherein the film wrap is a helical wrap.9. The device of claim 6, wherein the wire comprises hypo-tube and theat least one cut is spirally extending.